Clinical Study Evaluating an Acetabular Cup System After Total Hip Replacement

DePuy Orthopaedics1,593 enrolled

Overview

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,593

Conditions

Osteoarthritis Rheumatoid Arthritis Arthritis Avascular Necrosis Acute Fracture

Interventions

Acetabular cupDEVICE

Acetabular cup replacement

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Primary hip replacement * Sufficient bone stock to support implant * Signed Informed Patient Consent form Exclusion Criteria: * Prior renal transplant * History of active joint sepsis * Recent high dose of corticosteroids * Primary or secondary carcinoma in the last 5 years * Neurological disease * Psychosocial disease that would limit rehabilitation * Use of structural bone graft * Simultaneous participation in another hip study

Locations (1)

DePuy Orthopaedics

Warsaw, Indiana, United States

Outcomes

Primary Outcomes

Survivorship

Time frame: 5 years

Secondary Outcomes

Harris Hip Score

Time frame: Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

Short Form-36 (SF-36)

Time frame: Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.

Data from ClinicalTrials.gov

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